RecruitingNot ApplicableNCT02584270

Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue

Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue (PGSRT): a Randomized Clinical Trial


Sponsor

University of Michigan

Enrollment

40 participants

Start Date

Jan 2, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

This study will fill a scientific gap in the current knowledge providing data for evaluation of the palatal augmentation prosthesis (PAP) as a therapeutic modality post-surgery. This is a robust scientific randomized prospective clinical trial. Positive outcomes from this study have the potential to dramatically alter the most common issues of oral cancer therapy, namely speech and swallowing functions. Patients will have been diagnosed with a cancer lesion of the tongue requiring surgery and removal of part of the tongue. Smaller cancers of the tongue are sized as T1 or T2. For patients with smaller lesions, a PAP, which can aid in speaking and swallowing, is not routinely provided.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using a custom dental device (a specially shaped plate that fits in the roof of the mouth) to help patients with early-stage tongue cancer regain clear speech after surgery removes part of the tongue. **You may be eligible if...** - You have a new diagnosis of early-stage tongue cancer (T1 or T2, meaning relatively small tumors) - You are scheduled to have surgery for this cancer **You may NOT be eligible if...** - Your cancer has come back (recurrent disease) - You have previously had radiation therapy to the head or neck - You do not have enough upper teeth to support the palatal device Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPalatal Augmentation Prosthesis (PAP)

The palatal augmentation prosthesis, or PAP can improve speech and swallowing functions through reshaping the palatal contours. This may improve the contact between the tongue and hard palate as a person speaks or eats. It is meant to be created after adequate healing in patients with adequate motivation for improvements in their speech and swallowing. Regular wear and articulation therapy are necessary for this therapy to be effective.

OTHERArticulation Therapy

Subjects will receive the standard of care speech and articulation therapy in either arm.


Locations(1)

University of Michigan Department of Oral and Maxillofacial Surgery and Hospital Dentistry

Ann Arbor, Michigan, United States

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NCT02584270


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